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An Analysis of Potential Sex Differences in Knee Osteoarthritis

This study is currently Recruiting

September 2011 By Mayo Clinic

First Recieved on July 7, 2011

Last Updated on September 28, 2011

Sponsor: Mary O'Connor
Collaborators: Society of Women's Health Research
Information provided by: Mayo Clinic
Identifier: NCT01403207

Purpose

This pilot study will use tissues and fluids that are normally discarded during the course of total knee replacement surgery to investigate potential sex differences in knee osteoarthritis. Basic clinical demographic information will be obtained as well as preoperative functional and pain assessment scores, functional tests, and pressure pain threshold measurement. The purpose of the study will be to investigate if any sex differences can be identified in these tissues and to investigate if there appears to be any relationship between these differences and functional scores and tests.

Study Type: Observational
Study Design: Observational Model: Cohort, Time Perspective: Prospective

Eligibility

Ages Eligible for Study:65 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:Accepts Healthy Volunteers
Criteria

Inclusion Criteria: 1. Patient demographics (age, sex, BMI). 2. Clinical background material 1. Post menopausal female 2. List of all medications and supplements 1. Use of vitamin D supplements (duration and amount) 2. Use of bisphosphonates (past and current) 3. Use of estrogen (past and current) 3. Prior trauma or knee surgery 1. Have you ever injured the operative knee so badly that it was difficult for you to walk for at least one week? 2. Have you ever had any kind of knee surgery? Please include arthroscopy (where they put a scope in your knee), ligament repair surgery, or a meniscectomy (where they repaired or cut away a torn meniscus or cartilage)? 4. Prior intraarticular injections 1. Steroid 2. Hyaluronic acid 5. SF 12 6. WOMAC 7. PASE functional scale 8. Pain scale: The 11 question OARSI-OMERACT pain scale will be used. Patients will complete the pain scale within 2 weeks prior to surgery and at 3 months following surgery 9. Knee pain map: Patients will complete this within 2 weeks prior to surgery and at 3 months following surgery 10. Pressure pain thresholds at knee. This will be completed within 2 weeks prior to the surgery and at 3 months following surgery (see attachment for details) 3. Preoperative blood tests a. Vitamin D level 25 D3 should be measured 4. Standard preoperative radiographs: AP, lateral, standing flexion AP and patellar sunrise Exclusion Criteria: 1. Patients with inflammatory arthritis 2. Patients with osteonecrosis 3. Patients with prior upper tibial osteotomy 4. Premenopausal women 5. Patients under age 65 years, older than 75 years 6. Patients who are insulin dependent or diabetic 7. Patients with a BMI>30 8. Patients with a history of knee infection

Investigators

  • Investigator: Mary I O'Connor, MD - Principal Investigator - Mayo Clinic Jacksonville, Chair, Orthopedics

Locations

  • Mayo Clinic Jacksonville

    Jacksonville, Florida 32224 United States

Conditions related to this trial:

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